Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug Application for Uzedy extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. FDA. The sNDA is based on leveraging the existing clinical data for Uzedy coupled with the Agency’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BP-I.
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